Kornimate/medical-research-clean huggingface dataset:
dietary linoleic acid for secondary prevention of coronary heart disease and death in the sydney heart study: an rct

Conditions: Coronary Heart Disease

Summary: the substitution of polyunsaturated fatty acids (pufa) for saturated fatty acids (sfa) is a cornerstone of worldwide dietary advice for coronary heart disease (chd) risk reduction. however, clinical chd benefits specific to the omega-6 pufa linoleic acid (la), and distinct from omega-3 pufas, have not been established. the sydney diet-heart study (sdhs; 1966-1973) was a randomized controlled secondary chd prevention trial testing whether selectively increasing omega-6 la from safflower oil in place of sfa reduced chd and improved survival. a full analysis of mortality outcomes has not been published. the investigators recovered the original sdhs dataset, which included detailed longitudinal dietary, smoking and coded mortality data, permitting evaluation of smoking relapse rates, and all-cause, cvd and chd mortality outcomes by nutrient intake and duration of diet exposure. data recovery also permitted the first complete meta-analysis of la intervention trials on mortality outcomes. objectives are (1) to evaluate whether increasing dietary linoleic acid alters cvd and chd mortality, and (2) to assess whether changes in smoking relapse rates contribute to observed mortality differences.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of myocardial infarction, angina, or coronary insufficiency * willingness to attend coronary clinic in sydney australia on a regular basis
human sperm binding to transgenic mouse eggs

Conditions: Fertilization

Summary: at fertilization, the binding of sperm to the zona pellucida induces the acrosome reaction releasing lytic enzymes that facilitate the passage of the sperm through the zona. the sperm then fuses with the egg's plasm membrane and enters the egg's cytoplasm. the zona pellucida, an extracellular matrix composed of three glycoproteins (zp1, zp2, zp3), mediates the species-specific binding of sperm to egg. although homologous proteins are present in mouse and humans, human sperm will not bind to the mouse zona pellucida and when the zona pellucida is experimentally removed, human sperm will not bind or fuse to the mouse egg's plasm membrane. we have created transgenic mouse lines that express one or more human zona proteins. we wish to determine if human sperm will bind to these chimeric zonae and if this binding will induce the human sperm acrosome reaction. sperm and devitalized eggs will be collected by collaborating institution(s) under protocols and consent forms approved by that institution's irb. only procedures already being performed on subjects for diagnostic or treatment purposes will be used.

at fertilization, the binding of sperm to the zona pellucida induces the acrosome reaction releasing lytic enzymes that facilitate the passage of the sperm through the zona. the sperm then fuses with the egg s plasma membrane and enters the egg s cytoplasm. the zona pellucida, an extracellular matrix composed of three or four glycoproteins, mediates the species-specific binding of sperm to egg. although homologous proteins are present in mouse and humans, human sperm will not bind to the mouse zona pellucida and when the zona pellucida is experimentally removed, human sperm will not bind or fuse to the mouse egg's plasma membrane. we have established transgenic mouse lines that express one or more human or rat zona proteins. we wish to determine if human sperm will bind to these chimeric zonae and if this binding will induce the human sperm acrosome reaction. sperm and devitalized eggs will be collected by collaborating institution(s) under protocols and consent forms approved by that institution's irb. alternatively, anonymous fertile human sperm will be obtained from a commercial sperm bank using a donor consent agreement. only procedures already being performed on subjects for diagnostic or treatment purposes will be used.

Eligibility criteria:
* inclusion criteria: without regard to ethnic/race background, all subjects will be men and women over the age of 18 who are neither mentally retarded nor disabled.

Keywords: zona pellucida human eggs zp1, zp2, zp3 fertilization
persistant organics pollutants in breast cancer.

Conditions: Breast Cancer; Persistant Organic Pollutants; Lymph Node Metastases

Summary: persistant organics pollutants (pop) accumulate in the adipose tissue (at) and could modulate tumor progression as part of the microenvironment. the investigators tested the hypothesis that pops exposure may be associated with breast cancer metastasis analyzing the concentrations of 46 pops in both adipose tissue and serum samples from breast tumor patients (benign, malignant with and without lymph node metastasis)

the investigators set up a longitudinal prospective monocentric cohort study in the gynecologic-oncologic surgery department of european hospital georges-pompidou, with patients undergoing partial or total mastectomies, lymph node biopsies or axillary lymph node removal and sampling of the adipocytic tumour microenvironment to measure pops using gas chromatography coupled to high-resolution mass spectrometry. the objective is to analyze the concentrations of 46 pops including polychlorinated dibenzo(p)dioxins and furans (pcdd/fs), polychlorinated biphenyls (pcbs), polybromodiphenyl ethers (pbdes) and polybromobiphenyls (pbbs) in both adipose tissue (at) and serum samples from breast tumor patients (benign, malignant with and without lymph node metastasis).

Eligibility criteria:
inclusion criteria: * patient with breast tumor: benign or malignant * tumor size at least 1cm or palpable tumor * undergoing a breast surgery in european georges pompidou hospital * understanding the protocol and who signed a written consent exclusion criteria: patients unable to give informed consent * dementia * guardianship
outcomes in measurement-based treatment

Conditions: Depressive Disorder, Major

Summary: the primary objective for this study is to assess the impact of a measurement based treatment program (mbt) on major depressive disorder (mdd) remission rates in patients whose primary care provider (pcp) receives monthly patient-reported depression severity reports compared to patients whose pcp does not receive monthly reports.


Eligibility criteria:
inclusion criteria: * age ≥18 years old * diagnosis of major depressive disorder * prescribed a new prescription for an antidepressant medication on the date of study enrollment and currently taking the medication 'new' is defined as no antidepressant use in the previous 120 days * primary depression management is performed by the primary care provider * capable of self-management (i.e., taking medications and independently responding to follow-up contacts) * able to provide informed consent to participate * sufficient ability as judged by the physician to read, understand and complete survey instruments written in english and phone interviews spoken in english exclusion criteria: * history psychotic disorder or bipolar disorder * diagnosis of current postpartum depression * diagnosis of bereavement less than 8 weeks duration * currently pregnant * history of suicide attempts or current suicide plan * need for psychiatric hospitalization at enrollment visit * history of adjunctive treatments including electroconvulsive treatment (ect), vagus nerve stimulation (vns), transcranial magnetic stimulation (tms), magnetic seizure therapy (mst), or deep brain stimulation (dbs)
counter-regulatory impairment and the effect of microvascular insulin transfer in type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: the researchers plan to test the following hypothesis: a good level of glucose control in type 1 diabetes mellitus (t1dm) is dependent on two levels of feedback from the body: 1. the transport of insulin through small blood vessels: suggesting that hypoglycemia leads to increased insulin sensitivity which then causes recurrent hypoglycemia; 2. the endocrine level, defined as insulin-glucose interaction and hormonal counter-regulation. the researchers plan to investigate the relationships between hypoglycemia, insulin transport, and counter-regulation. this study will ultimately lead to a better understanding of risk for recurrent hypoglycemia.


Eligibility criteria:
inclusion criteria: * participated in and satisfied all of the inclusion criteria of nct00315939 * 18 years of age or older * have type 1 diabetes mellitus defined by american diabetes association criteria or judgment of physician * since our major goal is the investigation of hypoglycemia, we will preferentially recruit patients with a history of severe hypoglycemia/moderate hypoglycemia anticipating that approximately (\~) half of the recruited subjects will have had two or more severe or moderate hypoglycemia episodes in the past 12 months exclusion criteria: * age \< 18 * pregnancy * use of oral steroids * hematocrit \< 36% (females); \< 38% (males) * symptomatic heart disease (e.g., history of myocardial infarction, history of coronary bypass or stenting procedure, angina, episode of chest pain of cardiac etiology with documented ekg changes, positive stress test or catheterization with coronary blockages \> 50%) * history of an ischemic cerebrovascular event * active substance abuse * psychosis * mental retardation * severe depression
effect of the new definition of epilepsies of the ilae of 2014 on the diagnosis after the first seizure

Conditions: Seizure, Epileptic; Neuropsychology; Outcome

Summary: the present study is a prospective study on the development of seizure frequency, medication adherence, quality of life and cognitive performance after a first epileptic seizure using the new diagnostic criteria for epilepsy of the international league against epilepsy of 2014 at the time of diagnosis.

the new diagnostic criteria for epilepsy, which have been in place since 2014, suggest that due to the improved possibilities for early diagnosis and treatment - particularly as a result of improved imaging diagnostics - changes in the incidence rates and severity of the course of epilepsies with different etiologies can be expected. the group of epilepsies with unclear etiology should now be smaller than in previous studies. the mri- and eeg-positive patients can now be identified as having structural epilepsy based on the type of lesion, which was not possible in previous studies without differentiated imaging. the fact that these patients can now be treated before a patients can now be treated before a second seizure, the risk of recurrence and the health economic costs should also be reduced and have a positive effect on maintaining cognitive performance and quality of life after a first epileptic seizure. the aim of the study is to record the consequences of the new epilepsy diagnostic criteria in terms of outcome and treatment. in addition, the investigators will use a questionnaire battery and neuropsychological testing to record the potential neuropsychological deficits, financial and socio-medical consequences of a first seizure or early-stage epilepsy.

Eligibility criteria:
inclusion criteria: * completion of the 18th year of life * first epileptic seizure * ability to understand the patient information and to give written consent * written consent for voluntary participation in the study exclusion criteria: * chronic drug or alcohol abuse in the last two years

Keywords: first epileptic seizure definition of epilepsy neuropsychology outcome
venlafaxine er long-term extension study for major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: this is a phase 3, flexible-dose, open-label, multi-center study. the subjects who complete the week 8 visit in the prior double-blind study (b2411263) will be eligible to participate in this study. this study consists of 10 month treatment phase and 1-3 week tapering phase. the 2 follow-up visits will be evaluated after 2 weeks and 4 weeks of last study medication dosing.


Eligibility criteria:
inclusion criteria: * outpatients who have completed 8 weeks double-blind study (b2411263), without major protocol violations or tolerability concerns in the opinion of the investigator. exclusion criteria: * clinically important abnormalities on baseline (week 8 of the double-blind study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ecg), laboratory test results, or vital signs recorded before week 8 in the previous double-blind study. * significant risk of suicide based on clinical judgment. * use of prohibited treatments

Keywords: venlafaxine er long-term extension japan
opportunistic screening for osteoporotic vertebral fractures in patients with diffuse interstitial lung disease

Conditions: Osteoporosis; Interstitial Lung Disease; Vertebral Fracture

Summary: it is well known that some chronic respiratory pathologies such as asthma or chronic obstructive pulmonary disease (copd) are associated with an increased risk of osteoporosis, due to the pathology itself and the therapies implemented (per-os or inhaled corticosteroids). osteoporosis leads to an increased risk of fragility fracture, with an increased morbidity and mortality associated with severe fractures such as vertebral fractures. also, osteoporotic vertebral fractures often occur at the thoracolumbar hinge, resulting in worsening of the thoracic kyphosis. however, to the best of our knowledge, the prevalence of osteoporotic vertebral fractures measured by ct scan in patients with interstitial lung disease (ild) is not known. for these patients who already have impaired respiratory function, the appearance of vertebral fractures could impact their management and worsen their prognosis (additional restrictive syndrome, difficulties in analgesics management because of respiratory contraindications, difficulties in wearing a corset, etc...). in this context, it appears interesting to define the prevalence of osteoporosis and osteoporotic vertebral fractures at the thoracic spine and the thoraco-lumbar hinge in a population of patients followed for ild. so, the main objective of this study is to describe the prevalence of vertebral osteoporotic fractures in an overall cohort of patients with ild.


Eligibility criteria:
inclusion criteria: * patients older than 18 years old ; * patients included in the colibri database for ild between january 2017 and january 2023 ; * patients with a chest ct scan performed at the nice center university hospital. exclusion criteria: * absence of a thoracic ct scan performed at nice center university hospital * secondary vertebral fracture
mild intraoperative hyperventilation to decrease post-op. shoulder pain after lsg

Conditions: Laparoscopic Gastric Sleeve Surgery; ASA-I and II Risk Class Patients; Same Surgeon

Summary: shoulder pain is common after laparoscopic surgeries. multiple maneuvers are in use to decrease its incidence with variable results. this study aims to investigate the effect of mild hyperventilation to an end-tidal co2 level of 30-32 mmhg on the occurrence of postoperative shoulder pain. this is carried out through a comparison of the incidence of postoperative shoulder pain an intervention group to that in a control one with a normal end tidal co2 35-40 mmhg). controlling for all other variables.

this novel technique is based on the theory that shoulder pain is caused by diaphragmatic irritation by co2 during laparoscopic surgery. the investigators postulate that lowering the co2 level in the plasma, will lower tissue co2 level in the diaphragm and decrease the hypothesized irritation. in this study, patients will be divided into an interventional group which will receive mild intraoperative hyperventilation determined by an end-tidal co2 level of 30-32 mm hg and a control group in which end tidal co2 is kept at normal levels (35-40 mmhg). all other intraoperative factors will be standardized for all patients. patients will be followed up postoperatively and asked whether the participants developed shoulder pain as a primary study outcome. the pain will be recorded in terms of severity, site, and position, and any associations (nausea and vomiting). appropriate statistical tests will be used to check for any significant effects of the technique.

Eligibility criteria:
inclusion criteria: * 18 years old * no mental illnesses * american society of anesthesiologists (asa) class i\&ii, * patients undergoing laparoscopic sleeve gastrectomy. * no previous intrabdominal surgeries. exclusion criteria: * asa class \>ii, * previous abdominal surgeries. * mental illnesses.
efficacy and safety study in pancreatic or midgut neuroendocrine tumours having progressed radiologically while previously treated with lanreotide autogel® 120 mg

Conditions: Pancreatic Tumours; Midgut Neuroendocrine Tumours

Summary: this study aims to explore the efficacy and safety of lanreotide autogel® 120 mg administered every 14 days in subjects with grade 1 or 2, metastatic or locally advanced, unresectable pancreatic or intestinal neuroendocrine tumours (nets) once they have progressed on the standard dose of lanreotide autogel® 120 mg every 28 days.


Eligibility criteria:
inclusion criteria: * histopathologically confirmed, grade 1 or 2, metastatic or locally advanced, unresectable pnet (pnet cohort) or midgut net (midgut cohort) with or without hormone related syndromes, with a proliferation index (ki67) ≤20%. * positive somatostatin receptors type 2 * progression as assessed by an independent central reviewer according to recist v1.0 while receiving first line treatment with lanreotide autogel® at a standard dose of 120 mg every 28 days for at least 24 weeks exclusion criteria: * grade 3 or rapidly progressive (within 12 weeks) net * any net other than pancreatic and midgut * previous treatment with any antitumour agent for net other than lanreotide autogel® 120 mg every 28 days. exception made of prior treatment with octreotide at standard dose stopped for other reason than disease progression. * symptomatic gallbladder lithiasis at screening echography or history of cholelithiasis with no cholecystectomy since then.
hypofractionated intensity modulated radiation therapy plus hormonal therapy in patients with high risk prostate cancer

Conditions: High Risk Prostate Cancer

Summary: considering the promising results with hypofractionated in low and intermediate risk prostate cancer, our proposal is to translate this experience to patients with high risk prostate cancer. patients with high risk disease would receive hypofractionated rt to the prostate and to the external and internal iliac lymph nodes using imrt plus long-term hormonal therapy. the objective of the study is to show that long term grade\>2 late toxicity is acceptable and similar to published data using hypofractionated technique in the prostate only.


Eligibility criteria:
inclusion criteria: * pathologically proven diagnosis of adenocarcinoma of the prostate meeting one of the following conditions: * clinical stage \>t3 or * gleason score 8 or higher, or * psa level \>20ng/ml * study entry psa must be obtained within 6 weeks prior to protocol entry * ecog \<2 * age \>18 * history and physical examination within 3 months * bone scan and ct scan of the abdomen and pelvis within 3 months with no evidence of bone metastases and no pelvic lymph nodes larger than 1.0cm, unless biopsy negative. * cbc with differential within 6 weeks prior to protocol entry * absolute neutrophil count \>2000cells/mm3 * hemoglobin \>8.0 g/dl (the use of transfusion to increase the hg is acceptable) * testosterone level within 6 weeks of protocol entry * liver function tests * signed informed consent * prior use of hormonal therapy for prostate cancer is acceptable if less than 2 months. exclusion criteria: * prior use of hormonal therapy for prostate cancer for more than 2 months. previous use of finasteride or dutasteride is allowed. * prior invasive malignancy (except non-melanoma skin) unless disease-free for more than 5 years. * prior radiotherapy to the pelvis * life expectancy of less than 2 years.
a randomized controlled trial of menopausal tool/app for women

Conditions: Menopausal Symptoms; Menopause Symptom Management

Summary: the purpose of this study is about assessing the utilization of a mobile phone application (app), designed to improve the menopause experience of midlife women experiencing related symptoms and its association with menopause-related health care utilization


Eligibility criteria:
for patient enrollment: inclusion criteria: * women between the ages of 45 and 55 * english speaking (app only available in english) * able to provide informed consent * experiencing menopause symptoms, which will be assessed by a menopause rating scale (mrs) survey score of ≥ 5 * has an upcoming mayo clinic primary care appointment within 3 weeks of the enrollment and the mrs survey exclusion criteria: * lack of willingness to engage with app * inability to provide informed consent
safety of umbilical cord mesenchymal stem cell local intramuscular injection for treatment of uterine scars

Conditions: Uterine Scar

Summary: the purpose of this study is to evaluate the safety of umbilical cord mesenchymal stem cell local intramuscular injection for treatment of uterine scars by a prospective, single-center, open, and single-arm clinical trial.


Eligibility criteria:
inclusion criteria: * primiparous women receiving cesarean delivery * ages between 21-35 years * gestation ages ≥ 37 weeks and \< 42 weeks * willing to comply with study dosing and completed the entire course of the study * willing to give and sign an informed consent form and a photographic release form exclusion criteria: * fibroids * placenta previa * placenta abruption * multiple gestation * antepartum hemorrhage * preeclampsia/eclampsia * hepatic or renal dysfunction * any systemic uncontrolled disease * inability to provide consent

Keywords: mesenchymal stem cells cesarean section uterine scar
cardiac elastography to determine strain and strain rates in the heart

Conditions: Heart Disease

Summary: cardiac elastography is a new technique to analyze strain and strain rates in many organ systems, including the heart. in this study, cardiac elastography derived from the analysis of raw radiofrequency data obtained from a conventional clinical echocardiograph system will be compared to processed information that comes from the same echocardiograph system. the purpose of this study is to determine if cardiac elastography can accurately determine strain and strain rates as compared to more conventional means.


Eligibility criteria:
inclusion criteria: * healthy normal volunteers between the ages of 18-70 * patients scheduled for clinical echocardiogram between the ages of 18-70 who have known heart disease caused by myocardial infarction or cardiomyopathy exclusion criteria: * patients less than 18 years old, or greater than 70 years old * patients who do not have adequate quality echocardiographic images.

Keywords: echocardiography cardiac elastography normal volunteers